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Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial.一种名为 WIBP-CorV 的新冠灭活疫苗在健康儿童中的安全性和免疫原性:一项随机、双盲、对照、1/2 期临床试验的中期分析。
Front Immunol. 2022 Jun 24;13:898151. doi: 10.3389/fimmu.2022.898151. eCollection 2022.
2
Are COVID-19 vaccines safe for people with epilepsy? A cross-sectional study.新冠疫苗对癫痫患者安全吗?一项横断面研究。
Neurol Sci. 2022 Jun;43(6):3489-3496. doi: 10.1007/s10072-022-05956-6. Epub 2022 Feb 27.
3
Epilepsy and the risk of severe coronavirus disease 2019 outcomes: A systematic review, meta-analysis, and meta-regression.癫痫与严重 2019 冠状病毒病结局风险:系统评价、荟萃分析和荟萃回归。
Epilepsy Behav. 2021 Dec;125:108437. doi: 10.1016/j.yebeh.2021.108437. Epub 2021 Nov 15.
4
COVID-19 vaccine take-up rate and safety in adults with epilepsy: Data from a multicenter study in China.中国多中心研究中的 COVID-19 疫苗接种率和安全性在癫痫成人中的情况。
Epilepsia. 2022 Jan;63(1):244-251. doi: 10.1111/epi.17138. Epub 2021 Nov 21.
5
Safety and immunogenicity of an inactivated COVID-19 vaccine, BBIBP-CorV, in people younger than 18 years: a randomised, double-blind, controlled, phase 1/2 trial.一种名为 BBIBP-CorV 的新冠病毒灭活疫苗在 18 岁以下人群中的安全性和免疫原性:一项随机、双盲、对照、1/2 期临床试验。
Lancet Infect Dis. 2022 Feb;22(2):196-208. doi: 10.1016/S1473-3099(21)00462-X. Epub 2021 Sep 15.
6
Safety and tolerability of the novel 2019 coronavirus disease (COVID-19) vaccines among people with epilepsy (PwE): A cross-sectional study.新型 2019 冠状病毒病(COVID-19)疫苗在癫痫患者(PwE)中的安全性和耐受性:一项横断面研究。
Seizure. 2021 Nov;92:2-9. doi: 10.1016/j.seizure.2021.08.001. Epub 2021 Aug 6.
7
Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey.一种灭活全病毒 SARS-CoV-2 疫苗(克尔来福)的有效性和安全性:在土耳其进行的一项双盲、随机、安慰剂对照、3 期临床试验的中期结果。
Lancet. 2021 Jul 17;398(10296):213-222. doi: 10.1016/S0140-6736(21)01429-X. Epub 2021 Jul 8.
8
Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial.一项在健康儿童和青少年中进行的灭活 SARS-CoV-2 疫苗(科兴疫苗)的安全性、耐受性和免疫原性的双盲、随机、对照、1/2 期临床试验。
Lancet Infect Dis. 2021 Dec;21(12):1645-1653. doi: 10.1016/S1473-3099(21)00319-4. Epub 2021 Jun 28.
9
COVID-19 vaccination in patients with epilepsy: First experiences in a German tertiary epilepsy center.COVID-19 疫苗接种在癫痫患者中的应用:德国一家三级癫痫中心的初步经验。
Epilepsy Behav. 2021 Sep;122:108160. doi: 10.1016/j.yebeh.2021.108160. Epub 2021 Jun 21.
10
COVID-19 among patients with epilepsy: Risk factors and course of the disease.COVID-19 与癫痫患者:风险因素与疾病过程。
Epilepsy Behav. 2021 Jul;120:107996. doi: 10.1016/j.yebeh.2021.107996. Epub 2021 Apr 24.

儿童癫痫患者接种 COVID-19 疫苗的安全性和耐受性:一项前瞻性、多中心研究。

Safety and Tolerability of COVID-19 Vaccine in Children With Epilepsy: A Prospective, Multicenter Study.

机构信息

Department of Neurology, Qilu Hospital of Shandong University, Jinan, China.

Department of Neurology, Shandong Provincial Hospital, Jinan, China.

出版信息

Pediatr Neurol. 2023 Mar;140:3-8. doi: 10.1016/j.pediatrneurol.2022.11.018. Epub 2022 Dec 5.

DOI:10.1016/j.pediatrneurol.2022.11.018
PMID:36577181
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9721163/
Abstract

BACKGROUND

We designed this study to investigate the effects of the coronavirus disease 2019 (COVID-19) vaccine on epileptic seizures, as well as its adverse effects, in children with epilepsy (<18 years).

METHODS

This anonymous questionnaire study involved a multicenter prospective survey of outpatients and inpatients with epilepsy (<18 years) registered in epilepsy clinics in eight hospitals in six cities of Shandong Province.

RESULTS

A total of 224 children with epilepsy were included in the study. Fifty of them experienced general adverse events after vaccination. The most common local adverse events were pain or tenderness at the injection site. The most common systemic adverse effects were muscle soreness and headache. No severe adverse events were reported. There were no significant differences in the number of antiseizure medications (P = 0.459), gender (P = 0.336), etiology (P = 0.449), age (P = 0.499), duration of disease (P = 0.546), or seizure type (P = 0.475) between the patients with and without general adverse events. We found that the risk of seizure after vaccination was decreased in children who were seizure free for more than six months before vaccination. There was no significant difference in the number of seizures during the first month before vaccination, the first month after the first dose, and the first month after the second dose (P = 0.091).

CONCLUSION

The benefits of vaccination against COVID-19 outweighed the risks of seizures/relapses and severe adverse events after vaccination for children with epilepsy.

摘要

背景

本研究旨在探讨新冠病毒病 2019(COVID-19)疫苗对癫痫儿童(<18 岁)癫痫发作的影响及其不良反应。

方法

这是一项匿名问卷研究,涉及山东省六个城市八家医院癫痫诊所登记的癫痫门诊患者和住院患者(<18 岁)的多中心前瞻性调查。

结果

共纳入 224 例癫痫儿童。其中 50 例在接种疫苗后出现全身不良反应。最常见的局部不良反应是注射部位疼痛或压痛。最常见的全身不良反应是肌肉酸痛和头痛。未报告严重不良事件。有无全身不良反应的患者抗癫痫药物数量(P=0.459)、性别(P=0.336)、病因(P=0.449)、年龄(P=0.499)、病程(P=0.546)和发作类型(P=0.475)差异均无统计学意义。我们发现,在接种疫苗前 6 个月以上无发作的儿童中,接种后发生癫痫的风险降低。接种前第一个月、第一针后第一个月和第二针后第一个月的发作次数无显著差异(P=0.091)。

结论

对于癫痫儿童,接种 COVID-19 疫苗的益处超过了接种疫苗后癫痫发作/复发和严重不良反应的风险。